Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Shionogi

Status and phase: Completed; Phase 3

Conditions: Atrophy; Vaginal Diseases

Treatments: Drug: Ospemifene 60 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729469

15-50821

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

Enrollment: 919 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naturally or surgically menopausal
• Moderate or severe symptoms of vaginal atrophy
• 5% or fewer superficial cells in maturation index of vaginal smear
• Vaginal pH greater than 5.0
• Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Exclusion criteria

• Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
• Current vaginal infection requiring medication
• Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.

uterine or vaginal prolapse of Grade 2 or higher)

• Previous participation in any other ospemifene study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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919 participants in 2 patient groups, including a placebo group

Ospemifene 60 mg/day and K-Y® lubricant

Experimental group

Description:

Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Treatment:

Drug: Ospemifene 60 mg

Placebo and K-Y® lubricant

Placebo Comparator group

Description:

Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Treatment:

Drug: Placebo